High Resolution Microendoscopy for the Management of Esophageal Neoplasia

高分辨率显微内窥镜治疗食管肿瘤

• 批准号: 8759964
• 负责人: Sharmila Anandasabapathy
• 金额: $ 65.73万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-17 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8759964
• 关键词: Africa; Area; Benign; Biopsy; Caring; Cervix Uteri; Characteristics; China; Chinese People; Clinical; Colon; Communities; Computer software; Contrast Media; Country; Data; Devices; Diagnosis; Disease; Disease model; Early Diagnosis; Early identification; Effectiveness; Eligibility Determination; Endoscopy; Environment; Epithelial; Epithelium; Esophageal; Esophageal Squamous Cell; Evaluation; Geographic Locations; Goals; Health system; Hour; Image; Image Analysis; Incidence; Inflammation; Iran; Light; Lugol' s solution; Malignant Neoplasms; Malignant neoplasm of esophagus; Methods; Modeling; Morbidity - disease rate; Mucous Membrane; Multicenter Trials; Neoplasms; Nuclear; Operative Surgical Procedures; Optical Biopsy; Optics; Organ; Pathology; Patients; Performance; Pleomorphism; Population; Procedures; Randomized; Randomized Clinical Trials; Research Infrastructure; Resolution; Resources; Risk; Safety; Screening for cancer; Sensitivity and Specificity; Specificity; Staging; Staining method; Stains; Stomach; Survival Rate; System; Tablets; Techniques; Time; Tissues; Translating; United States; arm; base; chemoradiation; cost; cost effective; cost effectiveness; data acquisition; diagnostic accuracy; experience; follow-up; global health; high risk; improved; in vivo; mortality; novel; outcome forecast; pilot trial; programs; prospective; prototype; public health relevance; randomized trial; screening; success; trial comparing

DESCRIPTION (provided by applicant): Despite advances in chemoradiation therapy, the five-year survival rate for esophageal squamous cell neoplasia (ESCN) remains a dismal 15% due to diagnosis at a late, incurable stage. Endoscopic screening is typically performed in high-risk populations with Lugol's iodine staining of the mucosa and targeted biopsy of abnormal (unstained) areas. While Lugol's significantly increases the sensitivity of white light endoscopy (>95%), specificity remains poor (<65%) as inflammation and other benign mucosal changes mimic neoplasia. While confocal microendoscopy has been shown to dramatically enhance the diagnostic accuracy and yield of Lugol's chromoendoscopy, existing platforms are costly (>$150,000) and only available in a handful of tertiary centers worldwide. Our group has developed a portable, battery-operated, high-resolution microendoscope (mHRME) that provides subcellular images of the esophageal epithelium, delineating the cellular and morphologic changes associated with neoplasia. In a recent, single-arm pilot trial (R21), the HRME significantly increased the sensitivity and specificity of Lugol's screening to 100% and 89%. Based on our extensive preliminary data, we now propose to optimize and validate a lower-cost (<$1600), tablet-based system with a software interface that provides real- time image interpretation assistance, thus facilitating usage by less-experienced clinicians in low-resource settings. Our central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of endoscopic screening and surveillance. To validate this, we will conduct a randomized, multicenter trial of our 'optical biopsy' approach comparing it to the current standard of endoscopic screening/surveillance in the U.S. and China. In addition, we will construct, refine and analyze a disease model of ESCN to determine the effectiveness and cost-effectiveness of incorporating HRME into endoscopic screening and surveillance in both countries. Successful results can easily be translated to global cancer screening in other organs (cervix, colon, etc.).

描述（由申请人提供）：尽管放化疗取得了进步，但由于诊断已处于晚期、无法治愈阶段，食管鳞状细胞瘤 (ESCN) 的五年生存率仍然只有 15%。内窥镜筛查通常在高危人群中进行，对粘膜进行卢戈氏碘染色，并对异常（未染色）区域进行有针对性的活检。虽然卢戈氏显着提高了白光内窥镜检查的敏感性 (>95%)，但特异性仍然较差 (<65%)，因为炎症和其他良性粘膜变化类似于肿瘤。虽然共焦显微内窥镜已被证明可以显着提高 Lugol 色素内窥镜的诊断准确性和产量，但现有平台价格昂贵（> 150,000 美元），并且仅在全球少数三级中心提供。我们的团队开发了一种便携式、电池供电、高分辨率显微内窥镜 (mHRME)，可提供食管上皮的亚细胞图像，描绘与肿瘤相关的细胞和形态变化。在最近的一项单臂试点试验 (R21) 中，HRME 将 Lugol 筛查的敏感性和特异性显着提高至 100% 和 89%。基于我们广泛的初步数据，我们现在建议优化和验证一种低成本（<1600 美元）、基于平板电脑的系统，该系统具有可提供实时图像解释帮助的软件界面，从而方便经验不足的临床医生在低水平环境下使用- 资源设置。我们的中心假设是，这种“光学”方法将提高当前内窥镜筛查和监测标准的效率、临床影响和成本效益。为了验证这一点，我们将对我们的“光学活检”方法进行一项随机、多中心试验，将其与美国和中国当前的内窥镜筛查/监测标准进行比较。此外，我们将构建、完善和分析 ESCN 疾病模型，以确定将 HRME 纳入两国内镜筛查和监测的有效性和成本效益。成功的结果可以很容易地转化为其他器官（子宫颈、结肠等）的全球癌症筛查。